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Causes and risk factors
SSRIs and birth defects: can a new statistical approach resolve old controversies?
  1. Marco Tuccori1,
  2. Corrado Blandizzi2
  1. 1Unit of Adverse Drug Reaction Monitoring, University Hospital of Pisa, Pisa, Italy
  2. 2Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy
  1. Correspondence to Dr Marco Tuccori, Unit of Adverse Drug Reaction Monitoring, University Hospital of Pisa, Via Roma 55, Pisa 56126, Italy; marco.tuccori{at}gmail.com

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ABSTRACT FROM: Reefhuis J, Devine O, Friedman JM, et al. Specific SSRI and birth defects: Bayesian analysis to interpret new data in the context of previous reports. BMJ 2015;350:h3190.

What is already known on this topic

Several observational studies have been conducted on the use of selective serotonin reuptake inhibitors (SSRIs) in pregnancy and the risk of congenital malformations, providing conflicting results.1 Conflicting results among studies can be easily explained by methodological shortcomings that are often inherent to the clinical setting.2 For instance, since the outcomes are very rare, aggregate end points (ie, clusters of birth defects that may affect different organs and systems) are usually employed when the sample does not have sufficient power to detect an association. Likewise, aggregate exposures (ie, an entire drug class, such as SSRIs) can be adopted. These methodological decisions imply that all birth …

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